✔ Verified by Medical Jobs India
Hiring Associate GRAAS Operations
🏢 Amgen
📍 Hyderabad
🎓 Freshers / Early Career
📊 Regulatory Affairs
Amgen is hiring an Associate – GRAAS Operations. This role is ideal for candidates interested in Regulatory Affairs, GSIM, and clinical data management.
📋 Job Overview
- Role: Associate – GRAAS Operations
- Location: Hyderabad
- Department: Regulatory Affairs
- Type: Full-Time
- Domain: GSIM / Regulatory Data
📌 Key Responsibilities
- Monitor regulatory data and submission timelines
- Update regulatory document systems (RSDIMS)
- Manage clinical trial submissions
- Handle FDA Form 1572 & PANI submissions
- Maintain regulatory archives
- Support cross-functional teams
🎓 Education & Experience
Basic Requirements:
- Bachelor’s degree
- OR Associate’s degree + 4 years experience
- OR High School / GED + 6 years experience
Preferred:
- Experience in Regulatory Affairs operations
- Understanding of regulatory processes (FDA, EMA)
- Exposure to document systems (Veeva preferred)
💻 Required Skills
- Regulatory data management
- GMP awareness
- Attention to detail
- Communication skills
👉 Learn basics: Clinical Research Guide
💰 Salary & Benefits
- ₹4.5 – ₹8 LPA
- Global regulatory exposure
- Career growth in Regulatory Affairs
- Work with international teams
💡 Interview Tips
- Revise FDA & EMA basics
- Understand clinical trial process
- Learn document workflows
- Practice Quiz
📄 Resume Tips
- Add regulatory knowledge
- Highlight documentation experience
- Mention certifications
- Keep resume 1–2 pages
❓ FAQ
- Freshers eligible?
Yes (early career) - Location?
Hyderabad - Domain?
Regulatory Affairs - Growth?
Strong RA career path
🚀 Apply Now
15
📌 Note Before You Apply:
Kindly read the entire job description carefully before applying. Make sure your qualifications match the role.
.png)
.png)
